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Sunday, February 23, 2014

With cross-party support in Quebec’s National Assembly, the legislature was scheduled to pass Canada’s first legislation aimed at permitting assisted dying. The bill as it stood would have permitted assisted dying in very carefully circumscribed circumstances. To be eligible, patients must suffer from an incurable illness and be in an advanced stage of irreversible decline, there must be no prospect of an improvement of their condition, they must also suffer from constant and unbearable physical or psychological pain, and they must be legally competent when they ask for assistance. Oh, and, given that a large majority of Canadians support such legislation, they also added the proviso that you would have to be insured in Quebec, presumably to prevent us folks living in provinces run by church-controlled parliamentarians from driving over to Quebec when we have decided that our time has come.

No doubt, Mr. Harper’s attorney general stood at the ready; he would have taken this legislation to the Supreme Court of Canada. After all, while health care is a provincial matter, there’s also the federal Code criminalizing assisted dying. Quebec’s legislators in Bill 52 asserted loud and clear their authority over matters health care. Quebec’s attorney general would have been ordered to cease prosecuting health-care professionals who assist Quebecers in their dying, provided they adhered to the criteria laid out in the legislation. Mr. Harper’s government, having so far thrown not too much meat in the direction of the Conservatives’ evangelical voter base, would not have let this opportunity pass to represent the religious right’s interests in this matter.

Would have been, could have?

It didn’t happen, courtesy of Quebec’s Liberal party. Before I get to that, though, let’s take a step back and look briefly at the history of Quebec’s cross-party effort aimed at passing legislation that permits assisted dying in the province. Support for such legislation among Quebecers runs these days above 80%, so this particular legislative effort did not take a lot of political guts to put into motion. It all began with the province’s former Liberal premier Jean Charest installing a Committee on Dying with Dignity. After his defeat at the hands of the PQ, this cross-party supported initiative continued under the leadership of the PQ. Eventually Bill 52 was produced, again with support of all factions in the National Assembly. It took no less than four years of public hearings, expert testimony and parliamentary debate. In the end, the document produced was very much in sync with what you can describe as best European practice on this matter. That said, if you’re opposed for religious reasons to assisted dying, you won’t like it, no matter what. If you belong to the majority of Canadians who want such legislation to come about, the safeguards put in place to prevent abuse of the vulnerable would likely have swayed you to support this bill.

The last reading of this bill in the National Assembly this week was expected by most observers to be a mere formality. After all, the Liberals in the province started it all, the PQ continued the process. How often do these two parties, in Quebec of all places, agree on anything of substance?

Much to the horror of the Liberals in the National Assembly, the PQ currently enjoys an all-time high in opinion poll after opinion poll. They are well on course to form a majority government if an election were held today. The Liberals? Well, not so much.

There must have been some hope among Liberal party strategists that the budget the PQ planned to introduce would have permitted the Liberals to inflict some damage on the province’s governing party. They wanted to ensure the document could be properly debated after the two-week recess the National Assembly began at the close of business on Thursday. So they tried hard to drag out the debate on Bill 52 to prevent the PQ from introducing the budget this week.

The PQ, on the other hand, seems determined to call an election during the recess. Of course, the Liberals aren’t terribly keen on an election campaign in Quebec at this point in time. Their current leader, Philippe Couillard, is proving to be a vote destroyer not dissimilar to what Michael Ignatieff and Stephane Dion were for the federal Liberals. And now Couillard added another nail in the coffin of Quebec’s Liberal party. By means of procedural shenanigans, he prevented a vote on Bill 52. He claims, disingenuously, that there just wasn’t enough time to debate this bill properly. Unlike the PQ and the two other smaller parties in the National Assembly, the Coalition Avenir Quebec and Quebec Solidaire, the Liberals were not willing to stay long enough to permit a vote on Bill 52. As a result, Bill 52 died on the order table.

Remarkably, Couillard was quick to declare that if the Liberals form the next Quebec government, they would reintroduce Bill 52 unchanged. Now, you got to ask yourself three questions here: First, as the PQ’s Stephane Bedard pointed out, what exactly do the Liberals think hasn’t been discussed during the last four years of hearings and deliberations? Second, why would the Liberals, in the unlikely event that they form the next provincial government, introduce exactly the same bill that they could not support this last week? Surely they must have issues with the bill that worry them. Finally, if they don’t have serious problems with Bill 52, why didn’t they permit a vote on it?

It is pretty clear that the Liberals in Quebec sacrificed Bill 52 for purely election strategic reasons. Given the popularity of the bill in Quebec, let me predict that the PQ will hammer them in their election campaign also on this issue. It’s going to be a vote winner for them.

Udo Schuklenk holds the Ontario Research Chair in Bioethics and Public Policy at Queen’s University, between 2009 an 2011 he chaired an international expert panel drafting a report on end-of-life issues in Canada on behalf of the Royal Society of Canada. He tweets @schuklenk.

Saturday, February 08, 2014

Imagine you suffer from a catastrophic kind of illness, an illness that’s invariably going to kill you in the near future. Everything that you and your doctor know about the illness suggests that your death will be anything but peaceful. Doctors can deal with some of your symptoms and palliative care can address some of the pain you are experiencing. But that’s about it.

Sadly this scenario isn’t unrealistic. Many Canadians face this sort of situation today.

During a scheduled visit to your specialist doctor you learn that there’s a brand-new drug currently being tested that might just save your life, if it worked that is. The doctor has already inquired with the researchers testing the drug in a phase-three clinical trial and you would be eligible to participate in that trial.

Phase-three clinical trials are trials at which stage in the drug research and development process we know what its safety profile looks like and we have pretty good evidence to think that it’s effective to some extent. That is so because during earlier trials, involving initially animals and eventually other patients, sufficient evidence has been accumulated to justify letting the phase-three trial go ahead. Now the doctors are trying to recruit a fairly large number of patients in order to establish whether the drug is as good as they thought it is. The nature of your disease is such though that there is no standard therapy around to assist your struggle for survival. The trial design in such cases demands that the experimental agent is tested against a placebo control, a dummy pill. That’s done because we need to know, before doctors can confidently prescribe the drug to patients like yourself, that the drug is doing better than what is the status quo – ie no drug. It’s always possible that an experimental drug actually does worse than the dummy pill.

Now, ask yourself, if you were that patient: Would you be willing to participate in a last-chance clinical trial where you’d have a 50:50 chance of getting a dummy pill? You know already what the dummy pill would achieve: your death. Would you trust the investigators to pull the plug quickly enough for you to survive if they discovered that the experimental drug actually works? In case you want to get a better handle on how it feels to be faced with this sort of decision, check out this blog (adriennes.blog.com) by a Toronto-based melanoma patient.

Many people suffering catastrophic illnesses flat-out refuse to participate in research that’s designed as I have described it. Their argument is not about the trial methodology, it is sound. Their argument is about the ethics of providing dying people with a coercive offer: join my clinical research project on my conditions or die a predictably horrible death.

The good news is that the story doesn’t end here. It has been recognized by regulators both in Canada and elsewhere that such coercive offers to people fighting for their very survival are incompatible with the fundamental values of liberal democracies. We must not reduce patients suffering catastrophic illnesses to mere means to achieve our research objectives. While that’s nothing much other than an honorable principle, there’s also a more pragmatic reason for this. I’ll get to that in a moment.

Health Canada actually permits people who suffer catastrophic illnesses to access drugs that are in the clinical trials system, and they can do so without actually participating in the clinical trials I mentioned earlier. The agency runs a Special Access Program for these sorts of patients. The program permits patients to access the experimental agent without trial participation. In return they promise to have their doctors monitor the impact of the drug carefully and report it back to the manufacturer or whoever runs the clinical trial. One of the ethical reasons for this I have just mentioned. The pragmatic reason for this solution is this: it was discovered during the early days of the AIDS epidemic, when no life-preserving medication existed, that patients who are coerced into placebo controlled trials will simply cheat in order to get access to the actual experimental drug. HIV-infected people enrolled in ostensibly placebo-controlled trials and then took their drugs to chemists to find out who did and who didn’t get the active agent. They then started sharing the actual drug and dumped the placebo. That, of course, rendered the trial pretty useless. True volunteers would have accepted the uncertainties and volunteered to test whether the experimental agent is any better than the placebo control.

The problem patients with catastrophic disease who wish to access experimental drugs through our Special Access Program face today in Canada is two-fold: Health Canada leaves it up to pharmaceutical companies to decide whether or not they provide drugs to eligible patients. Manufacturers who have trouble recruiting sufficient numbers of patients into their trials could deny patients access to the experimental drug to encourage them to join the trial on their conditions. They might also have other reasons for refusing to provide catastrophically-ill patients with access to an experimental drug. Either way, we are back to square one: a coercive situation. This problem occurs more frequently in Canada than you might think. Here is a heart wrenching appeal (http://www.youtube.com/watch?v=olwDT7NPSsM) from one such patient, who has since died. A Toronto paper contacted me about another case recently, both cases interestingly involved pharmaceutical multinational Bristol Myers Squibb refusing to provide an experimental drug that the company is testing in a phase-three clinical trial right now. This issue should be addressed by Health Canada as a matter of urgency. The other problem is that manufacturers are permitted to charge for their experimental drug. That is unreasonable. It costs typically cents to produce such medicines – I am not talking research and development costs but actual production costs. There is no reason whatsoever why pharmaceutical companies should profit from experimental drugs. They should be compelled by Health Canada to provide such agents to clinically eligible patients, while the clinical trials are ongoing and the drug isn’t formally approved as a for-pay prescription medication. If Health Canada were to address these shortcomings of the present Special Access Program it would ensure that catastrophically ill patients are given a fairer shot at actually accessing these experimental drugs.

Udo Schuklenk hold the Ontario Research Chair in Bioethics and Public Policy at Queen’s University, he tweets @schuklenk

KINGSTON - I have been wondering for some time about the seeming decline of trust in and respect for expertise or considered expert opinions. What triggered it were two very personal experiences that I want to relay to you before I make a broader point.

The first example is the ongoing debates on the safety of vaccines. Well, when I say ongoing debates, they are not quite debates amongst experts. The consensus among experts is that vaccines do not cause autism and that it is highly advisable — life-saving in many cases — to get flu shots prior to flu season. And yet, talking to acquaintances and friends about the subject, I quickly discovered that the consensus among experts counts for precious little. One friend told me that his aunt is a nurse and she told him not to get flu shots — one does wonder where she would have received her training. A colleague told me that she would never (rolling eyes, voice raised) get flu shots, because she’s certain that they would be harming her body. When I wrote a piece suggesting that we have a moral obligation to our fellow citizens to get vaccinated because it would create herd immunity and so protect us individually as well as as a group, I quickly learned from comments under the article that the vast majority of public health experts who recommend this course of action are pharmaceutical industry shills, that taking some humbug homeopathic concoction would also do the trick, and the list goes on. Invariably, this noisemaking was accompanied by fairly aggressive language and deliberate attempts at denying one’s opponents’ expertise, morality and ultimately credibility. No scientific evidence was provided; at best there were links to Internet sites featuring alternative health “information.” The thing that I cannot wrap my head around is the apparent lack of trust in specialist professional consensus opinion among so many. Any bogus “alternative” take, no matter how silly, seems to carry more weight with very many of us. Perhaps it’s a sign that our experts need a lesson or two in communicating their knowledge and advice better.

The other example: a few weeks ago I posted a comment on the website of a national conservative newspaper. In question was an article on assisted dying and what I thought was misleading content in the article. I knew my way around the subject matter because in 2009 the Royal Society of Canada, our national academy of arts, humanities and sciences, asked me to chair an international expert panel tasked with drafting a major report on end-of-life issues in the country. Our multi-disciplinary team, consisting of senior clinicians, lawyers and philosophers, spent two years working more or less full time on producing what arguably constitutes a landmark book-length (onlinelibrary.wiley.com/doi/10.1111/bioe.2011.25.issue-s1/issuetoc) report on the subject matter. So, I had some expertise to comment on said article. Now, within a few minutes of me posting said comment, someone whose name I had never come across in discussions on this topic berated me, telling me that I should do my homework before commenting in public on such issues. I replied by posting a link to our report, suggesting that I had at least some claim to expertise on the subject matter. Within no time, the commenter had found me on the Internet — not a difficult task with a last name such as mine. To my surprise, she then proceeded to berate Queen’s University for hiring me. Scandalous! There was Queen’s University daring to hire someone with whom she happened to disagree. Clearly this showed the university’s utter incompetence. I will get back to that competence issue in a moment.

Of course, in a democracy (actually, everywhere), people are entitled to their views and should be able to express them — well, short of calling someone racist names, threatening to kill someone, that sort of thing. It seems to me, though, that the non-expert activists in the two cases I have just described believe that their views are just as valid as those of actual demonstrable experts capable of backing up their claims with facts. And that, of course, is utter nonsense. It just isn’t the case that the views of someone believing in homeopathy are as valid as those of someone who has done actual clinical research and can back up her views with research results that are testable and reproducible.

In some ways, I think, this rejection of expertise constitutes a threat to how we do business in our modern societies. Rationality and evidence were at the core of how we developed policies, and they should be at the core of how we ought to develop policies. As anyone who follows Canadian politics knows, since the advent of Stephen Harper’s reign, this isn’t the case any longer, either. He has shuttered crucial government research facilities simply because they produced evidence that conflicted with his ideological take on reality. It’s a make-believe world that is being created. Meanwhile, actual scientific expertise is deliberately destroyed in the process.

Funny enough, experts being what they are, have investigated this phenomenon, and there is even a name for it. It’s called the Dunning-Kruger effect. Basically, what it does is describe how people could possibly be as uninformed as they are and fail to notice that they really are clueless. Experimentally, the researchers were able to show, for instance, that the worst performing students consistently overrated the quality of their performance while the best performing were typically more skeptical about their place in the academic universe. So, as a writeup at Psychology Today(www.psychologytoday.com/blog/evolved-primate/201006/when-ignorance-begets-confidence-the-classic-dunning-kruger-effect) puts it: “People fail to grasp their own incompetence, precisely because they are so incompetent. And since overcoming their incompetence would first require the ability to distinguish competence from incompetence, people get stuck in a vicious cycle.”

I think the mass media — yes, let me finish this up with a quick round of media bashing — must take some responsibility for the mess we are getting ourselves into. Typically, any talk show, newspaper article, even news program, aims to provide for-and-against-type programming. Ostensibly, this is designed to demonstrate balance. But really it more often than not pits an actual expert against a Dunning-Kruger-effect-type activist. Yet they are happily put together on stage, quoted in newspaper articles as if their opinions carried the same value. What really happens here, however, is that audiences are misled by those who put those programs together.

So, there’s the problem. The question is, how can we fix it?

Udo Schuklenk isn’t an expert in most things, but he does claim expertise in a few things, he also teaches at Queen’s University and tweets @schuklenk.